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BackgroundThe past few decades saw considerable advances in research and dissemination of evidence-based psychotherapies, yet available treatment resources are not able to meet the high need for care for individuals suffering from depression or anxiety. Blended care psychotherapy, which combines the strengths of therapist-led and internet interventions, can narrow this gap and be clinically effective and efficient, but has rarely been evaluated outside of controlled research settings. ObjectiveThis study evaluated the effectiveness of a blended care intervention (video-based cognitive behavior therapy and internet intervention) under real-world conditions. MethodsThis is a pragmatic retrospective cohort analysis of 385 participants with clinical range depression and/or anxiety symptoms at baseline, measured using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7), who enrolled in blended care psychotherapy treatment. Participants resided in the United States and had access to the blended care intervention as a mental health benefit offered through their employers. Levels of depression and anxiety were tracked throughout treatment. Hierarchical linear modeling was used to examine the change in symptoms over time. The effects of age, gender, and providers on participants’ symptom change trajectories were also evaluated. Paired sample t-tests were also conducted, and rates of positive clinical change and clinically significant improvement were calculated. ResultsThe average depression and anxiety symptoms at 6 weeks after the start of treatment were 5.94 and 6.57, respectively. There were significant linear effects of time on both symptoms of depression and anxiety (β=–.49, P

BackgroundThe prevalence of obesity and associated metabolic conditions continue to be challenging and costly to address for health care systems; 71% of American adults were overweight, with 35% of men and 40% of women diagnosed with obesity in 2014. Digital health coaching is an innovative approach to decreasing the barriers of cost and accessibility of receiving health coaching for the prevention and management of chronic disease in overweight or obese individuals. ObjectiveTo evaluate the early impact of a mobile phone-based health coaching service on weight loss and blood pressure management in a commercially insured population. MethodsThis was a retrospective study using existing registry data from a pilot commercial collaboration between Vida Health and a large national insurance provider, which enrolled adult members who were overweight (body mass index >25 kg/m2) and able to engage in a mobile phone-based coaching intervention. Participants received 4 months of intensive health coaching via live video, phone, and text message through the Vida Health app. Participants were also provided with a wireless scale, pedometer, and blood pressure cuff. Of the 1012 enrolled, 763 (75.40%) participants had an initial weight upon enrollment and final weight between 3 and 5 months from enrollment; they served as our intervention group. There were 73 participants out of the 1012 (7.21%) who had weight data 4 months prior to and after Vida coaching, who served as the matched-pair control group. ResultsParticipants in the intervention group lost an average of 3.23% total body weight (TBW) at 4 months of coaching and 28.6% (218/763) intervention participants achieved a clinically significant weight loss of 5% or more of TBW, with an average of 9.46% weight loss in this cohort. In the matched-pair control group, participants gained on average 1.81% TBW in 4 months without Vida coaching and lost, on average, 2.47% TBW after 4 months of Vida coaching, demonstrating a statistically significant difference of 4.28% in mean percentage weight change (P120 mmHg); 55 out of 112 (49.1%) participants improved their blood pressure at 4 months by an entire hypertensive stage—as defined by the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. ConclusionsMobile phone app-based health coaching interventions can be an acceptable and effective means to promote weight loss and improve blood pressure management in overweight or obese individuals. Given the ubiquity of mobile phones, digital health coaching may be an innovative solution to decreasing barriers of access to much-needed weight management interventions for obesity.

Mobile phones and devices, with their constant presence, data connectivity, and multiple intrinsic sensors, can support around-the-clock chronic disease prevention and management that is integrated with daily life. These mobile health (mHealth) devices can produce tremendous amounts of location-rich, real-time, high-frequency data. Unfortunately, these data are often full of bias, noise, variability, and gaps. Robust tools and techniques have not yet been developed to make mHealth data more meaningful to patients and clinicians. To be most useful, health data should be sharable across multiple mHealth applications and connected to electronic health records. The lack of data sharing and dearth of tools and techniques for making sense of health data are critical bottlenecks limiting the impact of mHealth to improve health outcomes. We describe Open mHealth, a nonprofit organization that is building an open software architecture to address these data sharing and “sense-making” bottlenecks. Our architecture consists of open source software modules with well-defined interfaces using a minimal set of common metadata. An initial set of modules, called InfoVis, has been developed for data analysis and visualization. A second set of modules, our Personal Evidence Architecture, will support scientific inferences from mHealth data. These Personal Evidence Architecture modules will include standardized, validated clinical measures to support novel evaluation methods, such as n-of-1 studies. All of Open mHealth’s modules are designed to be reusable across multiple applications, disease conditions, and user populations to maximize impact and flexibility. We are also building an open community of developers and health innovators, modeled after the open approach taken in the initial growth of the Internet, to foster meaningful cross-disciplinary collaboration around new tools and techniques. An open mHealth community and architecture will catalyze increased mHealth efficiency, effectiveness, and innovation.

Contact lens neophytes often learn about contact lens insertion and removal through YouTube videos of unknown quality. This study evaluates the quality of soft contact lens insertion and removal videos on YouTube. A search for the keywords 'Contact lens insertion', 'Contact lens removal', 'Put in contact lens', and 'Take off contact lens' was performed on YouTube. The first 50 videos for each keyword were evaluated. The number of views, source of the publisher, days since upload, and video quality were scored based on the content in the videos. The maximum score of insertion and removal videos were 7 and 5 respectively. The videos were classified into three groups by publisher category: videos published by eye care professionals, companies and YouTubers. Only 45 contact lens insertion and 44 removal videos met the inclusion criteria and were analysed. Insertion and removal videos published by YouTubers had the highest view and view rate. However, their quality scores were significantly lower than videos published by eye care professionals and companies. Videos uploaded by companies had the highest scores (insertion: 5.00 ± 1.10; removal: 3.25 ± 0.75). The mean scores of insertion and removal videos published by YouTubers were 1.65 ± 0.93 and 1.00 ± 0.89, respectively, while the insertion and removal videos uploaded by eye care professionals scored 3.58 ± 2.07 and 2.75 ± 1.53, respectively. There was also a negative correlation between the quality scores and view rate (p = 0.008, r = -0.41). Contact lens insertion and removal videos uploaded by YouTubers had the highest view rate but the lowest quality. Videos made by companies included most essential elements. [ABSTRACT FROM AUTHOR]

What is this summary about? This summary describes an article published in the medical journal Frontiers in Oncology in September 2023. The article reports results from a study that looked at breast cancer treatments for older patients aged 75 years or older. The study focused on a type of cancer called HR+/HER2- metastatic breast cancer. HR+/HER2- stands for hormone receptorpositive/human epidermal growth factor receptor 2-negative. This study evaluated whether older patients with this type of cancer benefited from the combination of two medicines – palbociclib and an aromatase inhibitor – compared with taking an aromatase inhibitor alone. How was the study in this summary carried out? The Flatiron database contains medical records for people with cancer in the US. This study used deidentified health care information from this database. 'Deidentified' means that all information that could identify an individual was removed to protect individuals' privacy. People in this study received treatment in routine care and not in a clinical trial. What do the results mean? Older patients who took palbociclib plus an aromatase inhibitor lived longer than those who took an aromatase inhibitor alone. Older patients who took palbociclib plus an aromatase inhibitor also lived longer without their cancer getting worse and started chemotherapy later than those who took an aromatase inhibitor alone. These results support using palbociclib plus an aromatase inhibitor as the first treatment for patients aged 75 years or older with HR+/HER2- metastatic breast cancer. Tweetable abstract This study evaluated outcomes in elderly patients with metastatic breast cancer treated in routine care. Overall, patients who took palbociclib plus an aromatase inhibitor (AI) lived longer, and lived longer without their cancer getting worse, than those who took an AI alone. [ABSTRACT FROM AUTHOR]

What is this summary about? This summary is about a study that was published in the medical journal The Oncologist in July 2023. The combination of palbociclib with an aromatase inhibitor (AI) was approved by the FDA in 2015 as a treatment for people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2−) metastatic breast cancer (MBC). However, the effectiveness of palbociclib in African–Americans with MBC is not well studied. The goal of this study was to find out whether adding palbociclib to an AI helped African–Americans with HR+/HER2− MBC live longer. What are the key takeaways? This study used de-identified medical information from the Flatiron Database. This database contains healthcare information on people with cancer treated by doctors in the United States but personal information is removed to maintain privacy. Medical information for people who received certain treatments in routine clinical practice or real-world setting was included in the study. This study showed that in the real-world setting, African–Americans with HR+/HER2− MBC lived longer when receiving palbociclib with an AI than with an AI alone. Also, the study showed that African–Americans treated with palbociclib plus an AI lived longer without their cancer getting worse than those treated with an AI alone. What was the main conclusion reported by the researchers? These results support the use of palbociclib with an AI as a first treatment for African–Americans with HR+/HER2− MBC. Clinical Trial Registration:NCT05361655 (ClinicalTrials.gov) Plain language summary Effectiveness of palbociclib plus an aromatase inhibitor in African Americans with metastatic breast cancer in routine clinical practice: a plain language summary [ABSTRACT FROM AUTHOR]

Background: Palbociclib in combination with endocrine therapy is approved for treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer. In addition to clinical trials, several real-world studies have evaluated the effectiveness of palbociclib. With increased life expectancy in the general population, breast cancer in older women is also expected to increase. Objective: The aim was to systematically review evidence from both clinical trials and real-world studies for palbociclib treatment outcomes in older patients with HR+/HER2− advanced/metastatic breast cancer (a/mBC). Older patients are often underrepresented in clinical trials, and real-world evidence (RWE) will enrich the analysis of palbociclib outcomes in this subgroup of patients. Design: A systematic literature search in PubMed, EMBASE, and Cochrane Library through May 4, 2023, yielded 2355 unique articles. A total of 52 articles (13 and 39 articles reporting results from seven randomized controlled trials [RCTs] and 37 RWE studies, respectively) were included based on study eligibility criteria. Results: All RCTs used age cutoffs of ≥ 65 years to define older population (n = 722; 437 received palbociclib); all RWE studies, except one with an age cutoff of > 60 years, had age cutoffs of ≥ 65 years or higher to define older population (n = 9840; 7408 received palbociclib). Overall, in studies that compared efficacy (progression-free survival [seven RCTs, 20 RWE studies], overall survival [four RCTs, 11 RWE studies], tumor response [three RWE studies], and clinical benefit rate [one RCT, two RWE studies]) and safety outcomes (three RCTs, three RWE studies) between older and younger patients, palbociclib showed similar benefits, regardless of age. Results from two RCTs and two RWE studies showed that global quality of life (QoL) was maintained in older patients receiving palbociclib. Overall, palbociclib dose modifications (two RWE studies), dose reductions (one RCT, seven RWE studies), and treatment discontinuation rates (three RCTs, three RWE studies) were higher in older patients compared with younger patients; however, these differences did not appear to adversely impact efficacy outcomes. Conclusions: In this systematic review, data from RCTs showed that palbociclib was effective, well tolerated, and maintained QoL in older patients with HR+/HER2− a/mBC. Palbociclib treatment in older patients in real-world settings was associated with similar clinical benefit as in RCTs. PROSPERO Registration: CRD42023444195. [ABSTRACT FROM AUTHOR]

Aim: Provide real-world data on palbociclib as evidence of effectiveness in patient populations from routine clinical practice. Methods: This was a retrospective, observational cohort study of patients with HR+/HER2- metastatic breast cancer treated with palbociclib plus aromatase inhibitor (AI) or AI alone as first-line therapy within the US Oncology Network. Results: Patients treated with palbociclib plus AI (n = 838) versus AI alone (n = 450) had a numerically longer median overall survival (42.1 vs 35.7 months; hazard ratio [HR] = 0.90 [95% CI: 0.75–1.07]; p = 0.117) and a significantly extended real-world progression-free survival (21.0 vs 15.7 months; HR = 0.75 [95% CI: 0.64–0.88]; p = 0.0002) after normalized inverse probability treatment weighting. Conclusion: These real-world results support the use of palbociclib plus AI as first-line treatment in routine clinical practice for patients with HR+/HER2- metastatic breast cancer. This summary describes how well palbociclib works when used with an aromatase inhibitor in the real-world setting for people with a certain type of breast cancer that has spread to other areas of the body. Palbociclib stops cancer cells from growing and dividing. An aromatase inhibitor prevents the body from making the hormone estrogen, which is needed for certain types of breast cancer cells to grow. Palbociclib with an aromatase inhibitor is a standard first treatment used for people with this type of breast cancer that needs estrogen to grow and has spread to other areas of the body. In clinics, doctors may not always prescribe the two treatments together. The study wanted to find out if using the two treatments together worked better than using an aromatase inhibitor alone in the real-world setting. The results suggest that in this population of patients treated in a real-world setting, people with breast cancer that needs estrogen to grow and has spread to other areas of the body who were treated with palbociclib plus an aromatase inhibitor lived longer without their cancer getting worse than those treated with an aromatase inhibitor alone. The results support the use of palbociclib with an aromatase inhibitor as a first treatment for breast cancer that has spread to other areas of the body, rather than an aromatase inhibitor only. [ABSTRACT FROM AUTHOR]

In tall core-wall buildings with concrete unbonded post-tensioned flat-plate gravity framing, modeling the behavior of the slab-wallcolumn framing under earthquake loading can be crucial to determining structural response quantities for the design of the flat-plate framing. The outrigger action of the gravity system also affects the overall dynamic properties of the building and may affect wall moment and shear demands. The outrigger effect can be modeled using a slab-beam model, which uses linear-elastic frame elements with concentrated nonlinear hinges at each end. In this study, the slab-beam model is calibrated using results from a slab-wallcolumn laboratory test. Recommendations suitable for designoffice practice are presented. [ABSTRACT FROM AUTHOR]

There are limited real‐world comparative effectiveness data for palbociclib plus an aromatase inhibitor (AI) as a first‐line (1L) treatment examining endpoints that require long term follow‐up and post 1L progression. The Flatiron Health Analytic Database was used to characterize treatment and dosing patterns in patients with hormone receptor‐positive/human epidermal growth factor 2‐negative (HR+/HER2−) metastatic breast cancer (mBC) receiving palbociclib plus an AI vs an AI alone in routine US clinical practice. In addition, time to chemotherapy (TTC) and real‐world progression‐free survival (rwPFS) when combining 1L and second‐line of therapy (rwPFS2) were assessed. Of 1324 patients who received palbociclib plus an AI between February 3, 2015 and March 31, 2020, 1110 (83.8%) started palbociclib at the recommended 125 mg/day dose. After stabilized inverse probability treatment‐weighting (sIPTW), median TTC in patients treated with palbociclib plus an AI and AI alone was 37.4 months (95% confidence interval [CI], 33.7‐40.7) and 29.2 months (95% CI, 26.8‐33.5), respectively (hazard ratio [HR] = 0.77 [95% CI, 0.69‐0.86], P <.0001); median rwPFS2 was 32.6 months (95% CI, 29.4‐35.2) and 20.7 months (95% CI, 18.9‐22.6), respectively (HR = 0.62 [95% CI, 0.54‐0.70], P <.0001). Sensitivity analyses with propensity score matching showed similar results to sIPTW analyses. Results from this large real‐world study examining additional effectiveness outcomes beyond 1L rwPFS and overall survival support the use of palbociclib plus an AI as a 1L treatment for patients with HR+/HER2− mBC. [ABSTRACT FROM AUTHOR]

The Health and Environmental Sciences Institute Developmental and Reproductive Toxicology (HESI‐DART) group held a hybrid in‐person and virtual workshop in Washington, DC, in 2022. The workshop was entitled, "Interpretation of DART in Regulatory Contexts and Frameworks." There were 154 participants (37 in person and 117 virtual) across 9 countries. The purpose of the workshop was to capture key consensus approaches used to assess DART risks associated with chemical product exposure when a nonclinical finding is identified. The decision‐making process for determining whether a DART endpoint is considered adverse is critical because the outcome may have downstream implications (e.g., increased animal usage, modifications to reproductive classification and pregnancy labeling, impact on enrollment in clinical trials and value chains). The workshop included a series of webinar modules to train and engage in discussions with federal and international regulators, clinicians, academic investigators, nongovernmental organizations, contract research organization scientists, and private sector scientists on the best practices and principles of interpreting DART and new approach methodologies in the context of regulatory requirements and processes. Despite the differences in regulatory frameworks between the chemical and pharmaceutical sectors, the same foundational principles for data interpretation should be applied. The discussions led to the categorization of principles, which offer guidance for the systematic interpretation of data. Step 1 entails identifying any hazard by closely analyzing the data at the study endpoint level, while Step 2 involves assessing risk using weight of evidence. These guiding principles were derived from the collective outcomes of the workshop deliberations. [ABSTRACT FROM AUTHOR]

Simple Summary: Palbociclib combined with an aromatase inhibitor (AI) has been shown to be effective in clinical trials for people with HR+/HER2− breast cancer that has spread to other areas of the body, such as the lungs or liver. Evidence of palbociclib effectiveness in routine clinical practice can provide complementary support for clinical trial findings. This study used electronic health records of people with breast cancer that had spread to their lungs and/or liver to determine how well palbociclib plus an AI worked compared to an AI alone. The study showed that palbociclib plus an AI compared with an AI alone was associated with a 38% or 27% reduction in the risk of death for patients with breast cancer that had spread to the lungs or liver, respectively. These findings support the use of palbociclib plus an AI for people whose breast cancer has spread to their lungs or liver. A cyclin-dependent kinase 4/6 inhibitor combined with endocrine therapy is the standard of care for patients with hormone receptor-positive/human epidermal growth factor 2-negative (HR+/HER2−) metastatic breast cancer (mBC), but real-world effectiveness data for patients with lung or liver metastases are limited. This retrospective study included data from the US Flatiron Health database of patients with HR+/HER2− mBC and lung or liver metastases treated with first-line palbociclib (PAL) plus an aromatase inhibitor (AI) or an AI alone in routine clinical practice. Overall survival (OS) and real-world progression-free survival (rwPFS) were assessed. A total of 891 patients were included (622 with lung metastasis, 376 with liver metastasis, and 107 with both lung and liver metastasis). After stabilized inverse probability of treatment weighting to balance patient characteristics, PAL + AI versus AI alone was associated with significantly prolonged OS (HR = 0.62; p < 0.001) and rwPFS (HR = 0.55; p < 0.001) in patients with lung metastases and numerically longer OS (HR = 0.73; p = 0.056) and significantly longer rwPFS (HR = 0.57, p < 0.001) for those with liver metastases. Overall, PAL + AI versus AI alone was associated with prolonged OS and rwPFS in routine clinical practice, supporting the use of first-line PAL + AI for patients with HR+/HER2− mBC with lung and/or liver metastases. [ABSTRACT FROM AUTHOR]

Introduction: Hemoadsorption has emerged as an adjunctive therapy for sepsis, but its impact on antibiotic levels remains poorly defined. We conducted an in vivo experimental study to investigate the removal of vancomycin and gentamicin during hemoadsorption using the HA380 cartridge, a novel styrene-divinylbenzene copolymer cartridge. Methods: Six surgically prepared sheep were administered 2 g of vancomycin and 400 mg of gentamicin over 30 min, followed by a continuous infusion of vancomycin (20 mg/h). Hemoadsorption was implemented with a styrene-divinylbenzene copolymer HA380 cartridge at a blood flow of 120 mL/min. The removal ratio, sorbent-based clearance, and the mass removal rate were calculated for each time point. Results: The mean 10-min vancomycin removal ratio exceeded 90% and declined to 68.0% at 30 min; 52.8% at 60 min, and 28.0% by 4 h. Due to constant plasma flow, clearance varied proportionally with the removal ratio. Over 4 hours, the total mass removal was 556 mg (SD 106.3). For gentamicin, the mean 10-min removal ratio was 96.9% and the final ratio at 4 h remained 53.0%, with clearances changing proportionately. The total mass removal of gentamicin was 138 mg (SD 26.6) over 4 h. The sorbent-based clearance of vancomycin was significantly lower than that of gentamicin (Pgroup < 0.0001). Conclusion: The novel HA380 sorbent cartridge appears safe and achieves significant vancomycin and gentamicin removal over a four-hour period. This information can be used by clinicians to guide their prescription and consider the additional dosing of at least an extra 25–35% amount in patients receiving HA380 hemoadsorption therapy during sepsis. [ABSTRACT FROM AUTHOR]

Background: Elderly patients are generally underrepresented in oncology clinical trials; therefore, real-world data are needed to inform clinical management of elderly patients with hormone receptor--positive/human epidermal growth factor receptor 2--negative (HR+/HER2-) metastatic breast cancer (mBC). This subanalysis of the P-REALITY X study (NCT05361655) evaluated palbociclib treatment patterns and comparative effectiveness of palbociclib plus an aromatase inhibitor (AI) versus an AI alone among patients with HR+/HER2-mBC aged ≥ 75 years treated in routine clinical practice in the United States. Methods: This retrospective observational cohort study used electronic health records from the Flatiron Health Analytic Database. Palbociclib treatment patterns, overall survival (OS), real-world progression-free survival (rwPFS), and time to chemotherapy (TTC) were evaluated. Three methods were used for comparative analyses: (1) an unadjusted analysis, (2) stabilized inverse probability treatment weighting (sIPTW; primary analysis), and (3) propensity score matching (PSM; sensitivity analysis). Results: A total of 961 patients aged ≥ 75 years with HR+/HER2- mBC were identified who started palbociclib plus an AI (n = 313) or an AI alone (n = 648) as first-line (1L) therapy between February 2015 and March 2020 (data cut-off: September 30, 2020). Among patients in the palbociclib plus an AI group with a documented palbociclib starting dose (n = 306), approximately 75% started palbociclib at 125 mg/day, and approximately 40% experienced dose adjustment. After sIPTW, patients treated with palbociclib plus an AI versus an AI alone had significantly improved OS (median of 43.0 vs. 32.4 months; hazard ratio [HR], 0.66 [95% confidence interval (CI), 0.51--0.84]; P = 0.0007), rwPFS (median of 20.0 vs. 15.0 months; HR, 0.72 (0.59--0.89); P = 0.0021), and TTC (median of 40.2 vs. 27.4 months; HR, 0.69 [0.55--0.87]; P = 0.0014). These significant improvements in OS, rwPFS, and TTC remained consistent in the unadjusted analysis and after PSM. Conclusion: This real-world comparative analysis demonstrated that 1L palbociclib plus an AI is associated with improved effectiveness compared with an AI alone among patients with HR+/HER2 -mBC aged ≥ 75 years. These findings support palbociclib plus an AI as a standard-of-care 1L treatment for elderly patients with HR+/HER2- mBC. [ABSTRACT FROM AUTHOR]

Background Disparities in survival and clinical outcomes between African American and White patients with breast cancer (BC) are well documented, but African American patients have not been well represented in randomized clinical trials of CDK4/6 inhibitors. Real-world studies can provide evidence for effective treatment strategies for underreported patient populations. Patients and Methods This retrospective analysis of African American patients with HR+/HER2− metastatic breast cancer (mBC) from the Flatiron Health longitudinal database evaluated treatments for patients with BC in routine clinical practice in the US. Patients initiated first-line therapy with palbociclib plus an aromatase inhibitor (AI) or AI alone between February 2015 and March 2020. Outcomes assessed included overall survival (OS) and real-world progression-free survival (rwPFS) until September 2020. Results Of 270 eligible patients, 127 (median age 64 years) were treated with palbociclib + AI, and 143 (median age 68 years) were treated with an AI. Median follow-up was 24.0 months for palbociclib + AI and 18.2 months for AI-treated patients. Median OS was not reached (NR; 95% CI, 38.2-NR) in the palbociclib + AI group versus 28.2 months (95% CI, 19.2-52.8) in the AI group (adjusted HR, 0.56; 95% CI, 0.36-0.89; P  = .013). Median rwPFS was 18.0 months (95% CI, 12.4-26.7) in the palbociclib + AI group and 10.5 months (95% CI, 7.0-13.4) in the AI group (adjusted HR, 0.74; 95% CI, 0.47-1.17; P  = .199). Conclusion This comparative analysis of palbociclib + AI versus AI alone indicates that palbociclib combined with endocrine therapy in the first line is associated with improved effectiveness for African American patients with HR+/HER2− mBC in real-world settings. Trial number NCT05361655 [ABSTRACT FROM AUTHOR]